Sop for receiving the samples in microbiology laboratory

1.0       OBJECTIVE

To lay down a standard procedure for receiving the samples in microbiology lab.

2.0       SCOPE

This Standard Operating Procedure is applicable to Microbiological section in Quality Control

Department.

3.0       RESPONSIBILITY

            Microbiologist shall be responsible to follow the procedure mention in this SOP.

4.0       ACCOUNTABILITY

Department Head & QA Head shall be accountable for effective implementation and compliance of

this SOP.

5.0       ATTACHMENTS

Format for Water samples inward record                                                 – Attachment-I

Finished and In process samples inward record                                       – Attachment-II

Raw material inward record                                                                      – Attachment-III

Miscellaneous samples inward record                                                      – Attachment-IV

6.0       PROCEDURE

6.1           Water samples

6.1.1        Microbiology personnel shall perform the sampling and collection of water from sampling points as

per  SOP no. SOP/ML/012.

6.1.2        After collection of water samples microbiology personnel shall allot the AR. No. in the respective

Format as per attachment-I

6.1.3        Samples shall be transferred to the respective testing area.

6.2          Finish and In process samples

6.2.1       The finished and the In process samples comes into the quality control lab through quality

assurance department shall be received by microbiology personnel and allotted AR. No. is entered

in the format as per attachment-II.

6.3          Raw material

6.3.1        The chemical/microbiology personnel shall perform the sampling of raw material. The sample shall

be received by microbiology personnel and the allotted AR. No. is entered in the respective register

as per attachment-III..

6.4           Miscellaneous samples

6.4.1        The miscellaneous samples such as validation samples hold time samples and primary packaging

samples are received in microbiology lab through quality assurance department and sampled by the

microbiologist.

5.4.2        After receiving the sample the entry is done in the miscellaneous inward record in format as per

attachment-IV and AR. No. is allotted and the samples are distributed for testing.

7.0       REFERENCES

In-house

8.0       ABBREVIATIONS

SOP: Standard operating procedure

  1. No. : Analytical report number

QA : Quality Assurance

QC: Quality Control

9.0       DISTRIBUTION LIST

Quality Assurance Department

Quality Control Department

10.0     HISTORY OF REVISION

Version Number Effective Date Reason for Revision

 

 

 

 

 

 

 

 

Microbiology Labs Documents